Adverse Events
Conditions
Brief summary
The purpose of CLP-01 was to complete the safety endpoint of the closed trial and ensure that all safety data generated by IRR-CT-901-2013-01 was accounted for and accurately identified, verified, and independently adjudicated. CLP-01 does not include an evaluation of the efficacy or exploratory endpoints from IRR-CT-901-2013-01. CLP-01 did not enroll new subjects and relied solely on data collected in the subject source and medical records in IRR-CT-901-2013-01. CLP-01 was conducted between March 2020 and November 2021.
Detailed description
Between 2013 and 2016, Irrimax Corporation sponsored a prospective clinical study (IRR-CT-901-2013-01; NCT02255487) in the United States under IRB approval. IRR-CT-901-2013-01 defined primary and secondary efficacy, exploratory, and safety endpoints. The safety endpoint from IRR-CT-901-2013-01 was a clinical review and analysis of Adverse Events (AEs). However, IRR-CT-901-2013-01 was terminated early after the Interim Analysis primarily because of issues with the accuracy and completeness of the data collected for IRR-CT-901-2013-01, the lack of SoC standardization, and challenges assessing study endpoints arising out of the complexity of the trauma and co-morbidities of the subjects enrolled. The sole purpose of CLP-01 was to complete the safety endpoint for IRR-CT-901-2013-01. CLP-01 reviewed all AEs recorded in IRR-CT-901-2013-01 and identified additional AEs in the subject source and medical records. All AEs were assessed for severity and causality and were reviewed by the individual Principal Investigators (PIs) at each site and the CLP-01 Medical Monitor (MM).
Interventions
DEVICEIrrisept
Irrisept® is a manual, self-contained irrigation device designed for wound cleansing and irrigation. The solution is 0.05% Chlorhexidine Gluconate (CHG) in sterile water for irrigation, USP (99.95%). Irrisept contents include the solution, a 450 mL bottle, and the Irriprobe applicator. Irrisept is a manual, self-contained irrigation device that can produce 7-8 psi of pressure for effective wound cleansing and irrigation. The user squeezes the bottle to create streams of solution and directs the fluid from the applicator onto a wound. The mechanical action of the streams of fluid being applied over a wound removes particulates and debris. Subjects randomized to Irrisept on study protocol IRR-CT-901-2013-01 used the device, per the provided Instructions for Use. Those randomized to SoC received routine care, per the discretion of the investigator, and in accordance with the institution's guidelines.
DEVICEStandard of Care
Subjects randomized to SoC on study protocol IRR-CT-901-2013-01 used any SoC type, per the investigator's discretion. SoC types were not standardized. Sites recorded SoC information as free text. The following were recorded as SoC types: Saline (recorded as normal, warm and/or sterile saline or saline solution); Sodium Chloride (recorded as sodium chloride (NACL) or NACL 0.9%); SoC; Irrisept (recorded as normal saline & Irrisept and Irrisept); Chloraprep; Gentamicin & saline; unknown; and none.
Sponsors
Irrimax Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
The randomization methodology was controlled by the site for the IRR-CT-901-2013-01 trial. There was no additional randomization for CLP-01.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Previously consented subjects from the closed study * Subjects randomized to use Irrisept or SoC in the closed study * Subjects who had a procedure in the hospital * Subjects who used irrigation during the hospital procedure * Subjects who had data that could be monitored and verified
Exclusion criteria
-Subjects who did not meet all inclusion criteria The total number of subjects in this population - the mITT population - was 592.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All Adverse Events | up to 30 +/- 3 days | The primary endpoint was identification of all adverse events from subjects that participated in the closed study (Protocol #IRR-CT-901-2013-01; NCT #02255487). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjects With Device-Related Adverse Events | up to 30 +/- 3 days | The secondary endpoint was identification of the number subjects with device-related adverse events from those that participated in the closed study (Protocol #IRR-CT-901-2013-01; NCT #02255487). |
| Number of Device-Related Adverse Events | up to 30 +/- 3 days | Another secondary endpoint was identification of the overall number device-related adverse events from subjects that participated in the closed study (Protocol #IRR-CT-901-2013-01; NCT #02255487). |
| Number of Device Deficiencies | up to 30 +/- 3 days | For the Irrisept group only, any device deficiencies identified in the medical records and/or source documents (during the closed study when the study device was used, even if the deficiency was not associated with an AE), was recorded. |
Countries
United States
Participant flow
Recruitment details
CLP-01, a retrospective review study conducted between 03/2020 & 11/2021, did not enroll new subjects, but relied solely on data collected for the trial IRR-CT-901-2013-01.CLP-01's purpose was to complete the safety endpoint of the closed trial & ensure that all safety data generated by IRR-CT-901-2013-01 was accounted for & accurately identified, verified, & independently adjudicated. CLP-01 did not include an evaluation of the efficacy or exploratory endpoints from IRR-CT-901-2013-01.
Pre-assignment details
CLP-01 included safety data only from trial IRR-CT-901-2013-01. There were 636 ITT subjects (i.e., those who consented into IRR-CT-901-2013-01). There were 592 mITT subjects (i.e., those who consented, randomized to Irrisept or SoC, had a procedure, used irrigation during that procedure & had verifiable safety data. Of the 592 mITT subjects, 294 subjects were given Irrisept & 298 subjects were given SOC. The remaining 44 subjects had non-evaluable data & were not included in the analysis.
Participants by arm
| Arm | Count |
|---|---|
| Irrisept For subjects randomized to the investigational group, Irrisept was used during the surgical procedure, per the provided instructions for use. Baseline data for age, gender, race and region was not the purpose of CLP-01 and therefore was not collected for Irrisept subjects. The purpose of CLP-01 was to identify and assess adverse event causality and severity only. | 0 |
| Standard of Care (SoC) For subjects randomized to the control group, any SoC irrigation solution, preferred by the investigator, was used during the surgical procedure. Baseline data for age, gender, race and region was not the purpose of CLP-01 and therefore was not collected for SoC subjects. The purpose of CLP-01 was to identify and assess adverse event causality and severity only. | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 294 | 8 / 298 |
| other Total, other adverse events | 157 / 294 | 101 / 298 |
| serious Total, serious adverse events | 63 / 294 | 93 / 298 |
Outcome results
Primary
All Adverse Events
The primary endpoint was identification of all adverse events from subjects that participated in the closed study (Protocol #IRR-CT-901-2013-01; NCT #02255487).
Time frame: up to 30 +/- 3 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Irrisept | All Adverse Events | 894 Adverse Events |
| Standard of Care (SoC) | All Adverse Events | 962 Adverse Events |
Secondary
Number of Device Deficiencies
For the Irrisept group only, any device deficiencies identified in the medical records and/or source documents (during the closed study when the study device was used, even if the deficiency was not associated with an AE), was recorded.
Time frame: up to 30 +/- 3 days
Population: Device deficiencies were only reported for subjects randomized to Irrisept. Of the 294 subjects randomized to Irrisept, there were 43 device deficiencies. Device deficiencies were any inadequacy of the medical device with respect to its identity, quality, durability, reliability, safety and/or performance.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Irrisept | Number of Device Deficiencies | Inadequate identification | 0 Number of Device Deficiencies |
| Irrisept | Number of Device Deficiencies | Quality | 40 Number of Device Deficiencies |
| Irrisept | Number of Device Deficiencies | Reliability | 0 Number of Device Deficiencies |
| Irrisept | Number of Device Deficiencies | Safety | 0 Number of Device Deficiencies |
| Irrisept | Number of Device Deficiencies | Performance | 0 Number of Device Deficiencies |
| Irrisept | Number of Device Deficiencies | Malfunction | 0 Number of Device Deficiencies |
| Irrisept | Number of Device Deficiencies | User Error | 3 Number of Device Deficiencies |
Secondary
Number of Device-Related Adverse Events
Another secondary endpoint was identification of the overall number device-related adverse events from subjects that participated in the closed study (Protocol #IRR-CT-901-2013-01; NCT #02255487).
Time frame: up to 30 +/- 3 days
Population: Of the total 1856 adverse events, 894 occurred in subjects on Irrisept and 962 occurred in subjects on SoC. There were 1808 total unrelated AEs (856 for Irrisept \& 952 for SoC), 35 unlikely related AEs (30 for Irrisept \& 5 for SoC), 13 possibly related AEs (8 for Irrisept \& 5 for SoC) and 0 probably \& definitely related AEs (0 for Irrisept \& SoC).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Irrisept | Number of Device-Related Adverse Events | Unlikely Related AEs | 30 Device-related AEs |
| Irrisept | Number of Device-Related Adverse Events | Probably Related AEs | 0 Device-related AEs |
| Irrisept | Number of Device-Related Adverse Events | Possibly Related AEs | 8 Device-related AEs |
| Irrisept | Number of Device-Related Adverse Events | Definitely Related AEs | 0 Device-related AEs |
| Irrisept | Number of Device-Related Adverse Events | Unrelated AEs | 856 Device-related AEs |
| Standard of Care (SoC) | Number of Device-Related Adverse Events | Definitely Related AEs | 0 Device-related AEs |
| Standard of Care (SoC) | Number of Device-Related Adverse Events | Unrelated AEs | 952 Device-related AEs |
| Standard of Care (SoC) | Number of Device-Related Adverse Events | Unlikely Related AEs | 5 Device-related AEs |
| Standard of Care (SoC) | Number of Device-Related Adverse Events | Possibly Related AEs | 5 Device-related AEs |
| Standard of Care (SoC) | Number of Device-Related Adverse Events | Probably Related AEs | 0 Device-related AEs |
Secondary
Subjects With Device-Related Adverse Events
The secondary endpoint was identification of the number subjects with device-related adverse events from those that participated in the closed study (Protocol #IRR-CT-901-2013-01; NCT #02255487).
Time frame: up to 30 +/- 3 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Irrisept | Subjects With Device-Related Adverse Events | 220 Subjects with Device-related AEs |
| Standard of Care (SoC) | Subjects With Device-Related Adverse Events | 194 Subjects with Device-related AEs |